Benefits of Nigella Sativa in Children With Beta Thalassemia Major (Nigella)

April 24, 2017 updated by: Tanta University

Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study will be carried on children patients with β- thalassemia major attending The Hematology Unit of Pediatric Department at Tanta University Hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. Then Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of Nigella sativa in those patient.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 0000
        • Recruiting
        • Faculty of Medicine- Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Thalassemia with iron overload

Exclusion Criteria:

  • Thalassemia complicated with diabetes mellitus or hepatitis
  • Patients who discontinue treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: patients receiving Nigella
40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.
Drug: nigella sativ
nigella sativa powder (2 gm/day) for 3 consecutive months.
NO_INTERVENTION: patients not received nigella as controls
40 patients in the control group will not receive nigella sativa and continued on the usual chelators

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
malondialdehyde
Time Frame: 3 months
nmol serum level of malondialdehyde (nmol per liter)
3 months
cluster of differentation4 and 8(CD4 and CD8)
Time Frame: 3 months
CD4 and CD8 cell per cmm
3 months
total antioxidant
Time Frame: 3 months
total antioxidant(mmol per liter)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum iron
Time Frame: 3 months
microgram per dl
3 months
total iron binding capacity
Time Frame: 3 months
microgram per dl
3 months
serum ferritin
Time Frame: 3 months
ng per ml
3 months
complete blood count
Time Frame: 3 months
complete blood count
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Director: Mohamed Ramadan ELshanshory, prof, Professor of Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 26, 2016

First Posted (ESTIMATE)

June 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30794l03l16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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